Status:
COMPLETED
Insulin Delivery Using Microneedles in Type 1 Diabetes
Lead Sponsor:
Emory University
Collaborating Sponsors:
Thrasher Research Fund
Conditions:
Type 1 Diabetes Mellitus
Eligibility:
All Genders
8-18 years
Phase:
PHASE2
PHASE3
Brief Summary
The goal of this study is to determine if microneedles can effectively and painlessly deliver insulin to children and young adults with type 1 diabetes.
Eligibility Criteria
Inclusion
- ≥ 8 years of age
- \<19 years of age
- Type 1 Diabetes for at least 2 years
- Uses a conventional, FDA-approved insulin pump for the past year
- Uses Lispro insulin
- Mean hemoglobin A1C ≤ 8.5 % for the past year
- Body mass index ≤ 85th percentile for age
- Understand and be willing to adhere to the study protocol
Exclusion
- Type 2 Diabetes
- Acanthosis nigricans
- Clinically significant major organ system disease
- On glucocorticoid therapy
- Insulin requirement ≥ 150 U/day
- Illness on the day of the study
- Cognitive impairment (IQ \< 85 or \> 2 grades behind age-appropriate grade)
- Pregnant or breast-feeding (if female).
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00837512
Start Date
September 1 2008
End Date
July 1 2013
Last Update
January 8 2014
Active Locations (1)
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1
Emory University
Atlanta, Georgia, United States, 30322